The Association Between SIRI and POD in Older Patients

Surgery Clinical Trial

Official title:

The Potential Value of Systemic Inflammation Response Index on Postoperative Delirium in Older Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05797194
• Other study ID #: POD-SIRI
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Previous studies have shown that surgery and anesthesia-induced acute peripheral inflammation and neuroinflammation may lead to delirium after surgery. Systemic Inflammation Response Index (SIRI) is a more easily accessible and comprehensive inflammation marker derived from monocyte, neutrophil, and lymphocyte count, which has been investigated to assess the prognosis of cancer and infectious diseases. However, the relationship between SIRI and POD has yet to be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Hospital stay of at least 3 days
• More than or equal to 65 years old
• Elementary education or above
• Able to communicate
• American Society of Anesthesiologists (ASA) physical status I-III
• Mini-mental State Examination (MMSE) scores = 22 points

Exclusion Criteria:

• Preoperative delirium
• Severe mental diseases
• Autoimmune-illness, chronic infectious diseases, nervous system diseases and malignancies

Related Conditions & MeSH terms

• Delirium
• Elderly
• Postoperative Delirium
• Surgery

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confusion assessment method (CAM) score	Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.	Baseline (Before surgery)
Primary	CAM score	Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.	Postoperative day 1
Primary	CAM score	Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.	Postoperative day 2
Primary	CAM score	Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.	Postoperative day 3
Secondary	The level of systemic inflammation response index (SIRI) in peripheral blood.	The SIRI was calculated as neutrophil count × monocyte count/lymphocyte count.	Baseline (Before surgery)
Secondary	Mini-mental State Examination (MMSE) score	MMSE score ranges from 0 to 30 and higher score means better outcome.	Baseline (Before surgery)
Secondary	MMSE score	MMSE score ranges from 0 to 30 and higher score means better outcome.	postoperative day 1
Secondary	MMSE score	MMSE score ranges from 0 to 30 and higher score means better outcome.	postoperative day 3